NCT06059222

The Optimised Use of Romozosumab Study

Name: Clinical Trial NCT06059222
Creator: University of Aarhus
Keywords: Osteoporosis, Romosozumab, Phase 4, drug, clinical trial, Denmark

University of Aarhus·Phase 4·ClinicalTrials.gov·drugRecruiting

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Study focus

Disease/Condition: Osteoporosis
Drug/Device/Intervention: Romosozumab
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: University of Aarhus
Location: Aarhus, Denmark

Timeline & enrollment

Phase: Phase 4
Start date: Oct 02, 2023
End date: Aug 01, 2026
Enrollment: 270 participants

Primary outcome

Change in total hip BMD

Summary

OPTIMIST is a two-year, randomised, active controlled, open-label, multicentre intervention trial. OPTIMIST includes 3 treatment groups each comprising combinations of romosozumab (ROMO) and zoledronate (ZOL) treatment used in standard doses (210 mg monthly (sc) and 5 mg yearly (iv), respectively).  The study will investigate if it is possible to maximize the effect of romosozumab by giving it in 2 periods of 6 months interrupted by zoledronate for 12 months compared to romosozumab for 12 months uninterrupted followed by zoledronate for 12 months. The investigators will also evaluate if 6 months of romosozumab followed by 18 months of zoledronate is non-inferior to the standard regimen of romosozumab for 12 months followed by zoledronate for 12 months.

ICD-10 classifications

Osteoporosis, unspecifiedOther osteoporosisIdiopathic osteoporosisOsteoporosis in diseases classified elsewherePostmenopausal osteoporosis

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06059222
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06059222 through Pure Global AI's free database. This Phase 4 trial is sponsored by University of Aarhus and is currently Recruiting. The study focuses on Osteoporosis. Target enrollment is 270 participants.

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